Caries Involving Multiple Surfaces of ToothARTUSPNCT02217098
The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations
A study testing GIC Restorations, Carbomer Restorations and Compomer Restorations in people with Caries Involving Multiple Surfaces of Tooth and Dental Caries on Chewing Surface of Tooth, run by Daniela Prócida Raggio at 1 site in Brazil.
Trial summary
The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions. This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Caries Involving Multiple Surfaces of Tooth, Dental Caries on Chewing Surface of Tooth, Dental Caries Extending Into Dentine
- What is being tested?
- GIC Restorations, Carbomer Restorations and Compomer Restorations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to 10 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Healthy children, age: 4-8 years
- At least one occlusal or proximal carious lesion in primary molar involving dentin
- Cooperative behavior
- Presence of antagonist of the tooth
- Carious lesion involving dentin with dimensions bucco-lingual and mesio-distal not greater than 2.5mm, occluso-cervical not greater than 2.0mm
- Absence of tooth mobility and abscess or fistula near to the selected tooth
Who cannot join
- Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research.
Trial locations and contacts
1 site in 1 country.
About this study
The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions.
This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research.The ART treatments will be done by two dental students. The operators will receive the same ART-training. The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list. It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.
Read the detailed description
The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions.
This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected, 300 patients with one occlusal carie lesion and 300 different patients with occlusal proximal cavities. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research. The remaining carious lesions will be also be treated. The ART treatments will be done by two dental students. The operators will receive the same ART-training.
The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list.
The selected children can have or an occlusal (O) cavity or an occlusalproximal (OP) cavity. So, the stratum of the study is OP and O. So, one randomization list will be performed for occlusal cavities and another randomization list will be used for occlusal proximal cavities.
It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.
- Conditions
- Caries Involving Multiple Surfaces of Tooth, Dental Caries on Chewing Surface of Tooth, Dental Caries Extending Into Dentine
- Being tested
- GIC Restorations, Carbomer Restorations, Compomer Restorations
- Keywords
- ART, Occlusal, Occlusoproximal, Primary teeth
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIC RestorationsProcedure or surgery
Restorations using Glass Ionomer Cement
Carbomer RestorationsProcedure or surgery
Restorations using Glass Carbomer
Compomer RestorationsProcedure or surgery
Restorations using Compomer
| Study group | Role | What they receive |
|---|---|---|
| GIC Restorations | Active comparator | Restorations using Glass Ionomer Cement Receives: Procedure: GIC Restorations |
| Compomer Restorations | Experimental | Restorations using Compomer Receives: Procedure: Compomer Restorations |
| Carbomer Restorations | Experimental | Restorations using Glass Carbomer Receives: Procedure: Carbomer Restorations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate (longevity) of ART restorations using differents materials
The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and occlusoproximal caries in primary molars with ART under field conditions.
Measured: 6, 12, 24 and 36 months follow-up
Secondary outcomes (6)
Association between survival and gender
Measured: 6, 12, 24 and 36 months follow-up
Association between survival and DMFT (caries experience)
Measured: 6, 12, 24 and 36 months follow-up
Association between survival and occlusal contact after restoration
Measured: 6, 12, 24 and 36 months follow-up
Association between sucess and ICDAS of the adjacent tooth (if there is a dentin cavited lesion or not)
Measured: 6, 12, 24 and 36 months follow-up
Cost-effectiveness of the 3 materials and their association with survival rate
Measured: 6, 12, 24 and 36 months follow-up
Comparition between Success of the restoration and longevity of the teeth (with or without pulp damage and exfoliation in the normal time)
Measured: 6, 12, 24 and 36 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionFeb 2015
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Caries Involving Multiple Surfaces of ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Prócida Raggio
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Responsible party
- Sponsor-investigator, Daniela Prócida Raggio, University of Sao Paulo
- Investigators
- Daniela P Raggio, Professor, Principal investigator, Universidade de Sao Paulo - Faculdade de OdontologiaIsabel O Costa, PhD, Study director, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217098
- Sponsor's protocol ID
- FOUSP6808912
- Acronym
- ARTUSP
- Status last verified
- Nov 2018
- First submitted
- 21 May 2014
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bonifacio CC, Hesse D, Raggio DP, Bonecker M, van Loveren C, van Amerongen WE. The effect of GIC-brand on the survival rate of proximal-ART restorations. Int J Paediatr Dent. 2013 Jul;23(4):251-8. doi: 10.1111/j.1365-263X.2012.01259.x. Epub 2012 Aug 14.
PubMed 22891625de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012 Apr;16(2):429-41. doi: 10.1007/s00784-011-0513-3. Epub 2011 Jan 28.
PubMed 21274581Banerjee A, Kidd EA, Watson TF. In vitro evaluation of five alternative methods of carious dentine excavation. Caries Res. 2000 Mar-Apr;34(2):144-50. doi: 10.1159/000016582.
PubMed 10773632van Bochove JA, van Amerongen WE. The influence of restorative treatment approaches and the use of local analgesia, on the children's discomfort. Eur Arch Paediatr Dent. 2006 Mar;7(1):11-6. doi: 10.1007/BF03320809.
PubMed 17140522Carvalho TS, van Amerongen WE, de Gee A, Bonecker M, Sampaio FC. Shear bond strengths of three glass ionomer cements to enamel and dentine. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e406-10. doi: 10.4317/medoral.16.e406.
PubMed 20526266Cehreli SB, Tirali RE, Yalcinkaya Z, Cehreli ZC. Microleakage of newly developed glass carbomer cement in primary teeth. Eur J Dent. 2013 Jan;7(1):15-21.
PubMed 23408469Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29.
PubMed 22124610van Duinen RN, Kleverlaan CJ, de Gee AJ, Werner A, Feilzer AJ. Early and long-term wear of 'fast-set' conventional glass-ionomer cements. Dent Mater. 2005 Aug;21(8):716-20. doi: 10.1016/j.dental.2004.09.007.
PubMed 16026667Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087.
PubMed 17082278Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.
PubMed 8915958Kuhnisch J, Mansmann U, Heinrich-Weltzien R, Hickel R. Longevity of materials for pit and fissure sealing--results from a meta-analysis. Dent Mater. 2012 Mar;28(3):298-303. doi: 10.1016/j.dental.2011.11.002. Epub 2011 Dec 3.
PubMed 22137936Mickenautsch S, Mount G, Yengopal V. Therapeutic effect of glass-ionomers: an overview of evidence. Aust Dent J. 2011 Mar;56(1):10-5; quiz 103. doi: 10.1111/j.1834-7819.2010.01304.x.
PubMed 21332735Raggio DP, Hesse D, Lenzi TL, Guglielmi CA, Braga MM. Is Atraumatic restorative treatment an option for restoring occlusoproximal caries lesions in primary teeth? A systematic review and meta-analysis. Int J Paediatr Dent. 2013 Nov;23(6):435-43. doi: 10.1111/ipd.12013. Epub 2012 Nov 28.
PubMed 23190278Olegario IC, Hesse D, Mendes FM, Bonifacio CC, Raggio DP. Glass carbomer and compomer for ART restorations: 3-year results of a randomized clinical trial. Clin Oral Investig. 2019 Apr;23(4):1761-1770. doi: 10.1007/s00784-018-2593-9. Epub 2018 Aug 31.
PubMed 30171345
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations
- ClinicalTrials.gov ID
- NCT02217098
- Acronym / sponsor ID
- ARTUSP / FOUSP6808912
- Conditions
- Caries Involving Multiple Surfaces of Tooth, Dental Caries on Chewing Surface of Tooth, Dental Caries Extending Into Dentine
- Keywords
- ART, Occlusal, Occlusoproximal, Primary teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Daniela Prócida RaggioUniversity, hospital or other
- Collaborators
- Academic Centre for Dentistry in Amsterdam
- Study start
- Jul 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions.
This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research.The ART treatments will be done by two dental students. The operators will receive the same ART-training. The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list. It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.
Detailed description
The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions.
This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected, 300 patients with one occlusal carie lesion and 300 different patients with occlusal proximal cavities. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research. The remaining carious lesions will be also be treated. The ART treatments will be done by two dental students. The operators will receive the same ART-training.
The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list.
The selected children can have or an occlusal (O) cavity or an occlusalproximal (OP) cavity. So, the stratum of the study is OP and O. So, one randomization list will be performed for occlusal cavities and another randomization list will be used for occlusal proximal cavities.
It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GIC Restorations | Active comparator | Procedure: GIC RestorationsRestorations using Glass Ionomer Cement |
| Compomer Restorations | Experimental | Procedure: Compomer RestorationsRestorations using Compomer |
| Carbomer Restorations | Experimental | Procedure: Carbomer RestorationsRestorations using Glass Carbomer |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Healthy children, age: 4-8 years
- At least one occlusal or proximal carious lesion in primary molar involving dentin
- Cooperative behavior
- Presence of antagonist of the tooth
- Carious lesion involving dentin with dimensions bucco-lingual and mesio-distal not greater than 2.5mm, occluso-cervical not greater than 2.0mm
Key exclusion criteria (1 listed)
- Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIC RestorationsRestorations using Glass Ionomer Cement | Procedure or surgery | GIC Restorations |
| Carbomer RestorationsRestorations using Glass Carbomer | Procedure or surgery | Carbomer Restorations |
| Compomer RestorationsRestorations using Compomer | Procedure or surgery | Compomer Restorations |
Primary outcome
Survival rate (longevity) of ART restorations using differents materials
Time frame: 6, 12, 24 and 36 months follow-up
The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and occlusoproximal caries in primary molars with ART under field conditions.
6 secondary outcomes
Association between survival and gender
Time frame: 6, 12, 24 and 36 months follow-up
Association between survival and DMFT (caries experience)
Time frame: 6, 12, 24 and 36 months follow-up
Association between survival and occlusal contact after restoration
Time frame: 6, 12, 24 and 36 months follow-up
Association between sucess and ICDAS of the adjacent tooth (if there is a dentin cavited lesion or not)
Time frame: 6, 12, 24 and 36 months follow-up
Cost-effectiveness of the 3 materials and their association with survival rate
Time frame: 6, 12, 24 and 36 months follow-up
Comparition between Success of the restoration and longevity of the teeth (with or without pulp damage and exfoliation in the normal time)
Time frame: 6, 12, 24 and 36 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
- Background: PubMed 22891625Bonifacio CC, Hesse D, Raggio DP, Bonecker M, van Loveren C, van Amerongen WE. The effect of GIC-brand on the survival rate of proximal-ART restorations. Int J Paediatr Dent. 2013 Jul;23(4):251-8. doi: 10.1111/j.1365-263X.2012.01259.x. Epub 2012 Aug 14.
- Background: PubMed 21274581de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012 Apr;16(2):429-41. doi: 10.1007/s00784-011-0513-3. Epub 2011 Jan 28.
- Background: PubMed 10773632Banerjee A, Kidd EA, Watson TF. In vitro evaluation of five alternative methods of carious dentine excavation. Caries Res. 2000 Mar-Apr;34(2):144-50. doi: 10.1159/000016582.
- Background: PubMed 17140522van Bochove JA, van Amerongen WE. The influence of restorative treatment approaches and the use of local analgesia, on the children's discomfort. Eur Arch Paediatr Dent. 2006 Mar;7(1):11-6. doi: 10.1007/BF03320809.
- Background: PubMed 20526266Carvalho TS, van Amerongen WE, de Gee A, Bonecker M, Sampaio FC. Shear bond strengths of three glass ionomer cements to enamel and dentine. Med Oral Patol Oral Cir Bucal. 2011 May 1;16(3):e406-10. doi: 10.4317/medoral.16.e406.
- Background: PubMed 23408469Cehreli SB, Tirali RE, Yalcinkaya Z, Cehreli ZC. Microleakage of newly developed glass carbomer cement in primary teeth. Eur J Dent. 2013 Jan;7(1):15-21.
- Background: PubMed 22124610Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29.
- Background: PubMed 16026667van Duinen RN, Kleverlaan CJ, de Gee AJ, Werner A, Feilzer AJ. Early and long-term wear of 'fast-set' conventional glass-ionomer cements. Dent Mater. 2005 Aug;21(8):716-20. doi: 10.1016/j.dental.2004.09.007.
- Background: PubMed 17082278Ersin NK, Candan U, Aykut A, Oncag O, Eronat C, Kose T. A clinical evaluation of resin-based composite and glass ionomer cement restorations placed in primary teeth using the ART approach: results at 24 months. J Am Dent Assoc. 2006 Nov;137(11):1529-36. doi: 10.14219/jada.archive.2006.0087.
- Background: PubMed 8915958Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.
- Background: PubMed 22137936Kuhnisch J, Mansmann U, Heinrich-Weltzien R, Hickel R. Longevity of materials for pit and fissure sealing--results from a meta-analysis. Dent Mater. 2012 Mar;28(3):298-303. doi: 10.1016/j.dental.2011.11.002. Epub 2011 Dec 3.
- Background: PubMed 21332735Mickenautsch S, Mount G, Yengopal V. Therapeutic effect of glass-ionomers: an overview of evidence. Aust Dent J. 2011 Mar;56(1):10-5; quiz 103. doi: 10.1111/j.1834-7819.2010.01304.x.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela P Raggio, Professor principal investigator
Universidade de Sao Paulo - Faculdade de Odontologia
Isabel O Costa, PhD study director
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIC Restorations, Carbomer Restorations and Compomer Restorations in people with Caries Involving Multiple Surfaces of Tooth and Dental Caries on Chewing Surface of Tooth, run by Daniela Prócida Raggio at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival rate (longevity) of ART restorations using differents materials (time frame: 6, 12, 24 and 36 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217098, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.